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LyoSens™

Women’s Health v1.0 Genotyping qPCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685214527813
Basic UDI-DI: 868521452PCR180GC
Reference: LYO180WS24
EMDN: W0105041004
EMDN description: FULL GENOTYPING HIGH-RISK + LOW-RISK HPV - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 23.09.2026 14:23

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ChainFor™

LYO179WS24

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685214527004
Basic UDI-DI: 868521452PCR179GT
Reference: CFP179P25
EMDN: W0105041002
EMDN description: SCREENING HIGH-RISK HPV - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 23.09.2026 14:23

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LyoSens™

Respiratory v5.0 Genotyping qPCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685214523594
Basic UDI-DI: 868521452PCR152G7
Reference: LYO152WS24
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 23.09.2026 14:23

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ChainFor™

Respiratory v4.0 Genotyping qPCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685115804723
Basic UDI-DI: 868521452PCR151G5
Reference: CFP151P25
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 23.09.2026 14:23

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RapidFor™

SARS-CoV-2 + FLU A/B + RSV + ADV Test Kit

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684998274272
Basic UDI-DI: 868354825VMD79SC4C
Reference: VMD79TD01
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Türkiye
Authorised representative: -
Last updated: 23.09.2026 14:23

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ChainFor™

Treponema pallidum qPCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595034460
Basic UDI-DI: 868511580PCR105GD
Reference: CFP105P100
EMDN: W0105010305
EMDN description: SYPHILIS DETECTION BY NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 23.09.2026 14:22

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ChainFor™

EBV Quantitative qPCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595034392
Basic UDI-DI: 868499827PCR110YB
Reference: CFP110P25
EMDN: W0105040403
EMDN description: EBV - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 23.09.2026 14:21

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ChainFor™

Respiratory v3.0 Genotyping qPCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595030790
Basic UDI-DI: 868511580PCR103G9
Reference: CFP103P100
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 23.09.2026 14:21

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QA Nucleic Acid Extraction Kit(Magnetic Bead Method)

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Jiangsu Q-Array Co.,Ltd.
Manufacturer SRN: CN-MF-000044646
UDI-DI: 06975050592406
Basic UDI-DI: 69750505924W6
Reference: Q001-48G
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: Caretechion GmbH
Last updated: 23.09.2026 13:52

Manufacturer products Authorised representative products Authorised representative actors View details

04562185395280

TRCR MB-Lysis Reagent

IVD generalIVDR 2017/746No longer on the marketProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 04562185395280
Basic UDI-DI: B-04562185395280
Reference: 0056202
EMDN: W0105010799
EMDN description: MYCOBACTERIA REAGENTS - OTHER
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 23.09.2026 13:26

Manufacturer products Authorised representative products Authorised representative actors View details

autotest VIH® 2nd GENERATION

IVD Class DIVDR 2017/746On the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: AAZ PRODUCTIONS LE MATERIEL BIOMEDICAL
Manufacturer SRN: FR-MF-000015889
UDI-DI: 03401562920213
Basic UDI-DI: 3770011742ASVIH0501002U
Reference: AS-VIH-001 ; AS-VIH-006 ; AS-VIH-012 ; AS-VIH-015
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: France
Safety summary (SSCP/SSP): AAZ.AV.106 · Rev. C
Authorised representative: -
Last updated: 23.09.2026 12:28

Manufacturer products Open in EUDAMED View details

RapidFor™

SARS-CoV-2 + FLU A/B + RSV + ADV Test Kit

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595037232
Basic UDI-DI: 868354825VMD79SC4C
Reference: VMD79SC01
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Türkiye
Authorised representative: -
Last updated: 23.09.2026 11:50

Manufacturer products View details

autotest VIH® 2nd GENERATION

IVD Class DIVDR 2017/746On the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: AAZ PRODUCTIONS LE MATERIEL BIOMEDICAL
Manufacturer SRN: FR-MF-000015889
UDI-DI: 05903205791436
Basic UDI-DI: 3770011742ASVIH0501002U
Reference: AS-VIH-011
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: -
Safety summary (SSCP/SSP): AAZ.AV.106 · Rev. C
Authorised representative: -
Last updated: 23.09.2026 10:45

Manufacturer products Open in EUDAMED View details

autotest VIH® 2nd GENERATION

IVD Class DIVDR 2017/746On the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: AAZ PRODUCTIONS LE MATERIEL BIOMEDICAL
Manufacturer SRN: FR-MF-000015889
UDI-DI: 08436565983434
Basic UDI-DI: 3770011742ASVIH0501002U
Reference: AS-VIH-004
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: -
Safety summary (SSCP/SSP): AAZ.AV.106 · Rev. C
Authorised representative: -
Last updated: 23.09.2026 10:45

Manufacturer products Open in EUDAMED View details

autotest VIH® 2nd GENERATION

IVD Class DIVDR 2017/746On the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: AAZ PRODUCTIONS LE MATERIEL BIOMEDICAL
Manufacturer SRN: FR-MF-000015889
UDI-DI: 09003622006062
Basic UDI-DI: 3770011742ASVIH0501002U
Reference: AS-VIH-014
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: -
Safety summary (SSCP/SSP): AAZ.AV.106 · Rev. C
Authorised representative: -
Last updated: 23.09.2026 10:44

Manufacturer products Open in EUDAMED View details

Alinity

Alinity i HAVAb IgM

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: ABBOTT GmbH
Manufacturer SRN: DE-MF-000009455
UDI-DI: 00380740135058
Basic UDI-DI: 038074AIR0228LB
Reference: 02R2801
EMDN: W0105080902
EMDN description: HEPATITIS VIRUS STANDARDS AND CALIBRATORS - INF.IMM.
First on market country: Germany
Authorised representative: -
Last updated: 23.09.2026 09:00

Manufacturer products View details

Alinity

Alinity i HAVAb IgG

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: ABBOTT GmbH
Manufacturer SRN: DE-MF-000009455
UDI-DI: 00380740131319
Basic UDI-DI: 038074AIP0826LF
Reference: 08P2601
EMDN: W0105080902
EMDN description: HEPATITIS VIRUS STANDARDS AND CALIBRATORS - INF.IMM.
First on market country: Germany
Authorised representative: -
Last updated: 23.09.2026 08:59

Manufacturer products View details

ARCHITECT

Architect HAVAb- IgM

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: ABBOTT GmbH
Manufacturer SRN: DE-MF-000009455
UDI-DI: 00380740009335
Basic UDI-DI: 038074ARC0630K2
Reference: 06C3001
EMDN: W0105080902
EMDN description: HEPATITIS VIRUS STANDARDS AND CALIBRATORS - INF.IMM.
First on market country: Germany
Authorised representative: -
Last updated: 23.09.2026 08:59

Manufacturer products View details

ARCHITECT

ARCHITECT Toxo IgM

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: ABBOTT GmbH
Manufacturer SRN: DE-MF-000009455
UDI-DI: 00380740009229
Basic UDI-DI: 038074ARC0620JX
Reference: 06C2001
EMDN: W0105080905
EMDN description: PARASITOLOGY STANDARDS AND CALIBRATORS - INF.IMM.
First on market country: Germany
Authorised representative: -
Last updated: 23.09.2026 08:59

Manufacturer products View details

ARCHITECT

ARCHITECT Toxo IgG

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: ABBOTT GmbH
Manufacturer SRN: DE-MF-000009455
UDI-DI: 00380740009182
Basic UDI-DI: 038074ARC0619KE
Reference: 06C1901
EMDN: W0105080905
EMDN description: PARASITOLOGY STANDARDS AND CALIBRATORS - INF.IMM.
First on market country: Germany
Authorised representative: -
Last updated: 23.09.2026 08:59

Manufacturer products View details